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Case Series of New Alloplastic Bone Graft Material

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221557
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sunstar Americas

Brief Summary:
A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.

Condition or disease Intervention/treatment Phase
Periodontology Oral Surgery Device: easy-graft (beta-Tricalcium Phosphate) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Histomorphometric Evaluation of Beta-tricalcium Phosphate/Polylactide Bone Substitute for Socket Preservation
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: New alloplastic bone graft material Device: easy-graft (beta-Tricalcium Phosphate)



Primary Outcome Measures :
  1. Percentage Change in Radiographic Measurement of Alveolar Ridge Height [ Time Frame: Change from baseline to 6 months ]
    Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have read, understood and signed a consent form.
  • 18-75 years of age
  • Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.

Exclusion Criteria:

  • Active caries or endodontic lesions in adjacent teeth
  • Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)
  • Taking any medication known for gingival hyperplasia for past 3 months.
  • Any systemic contraindications to surgery
  • Subject smokes > 10 cigarettes per day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221557


Locations
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United States, Maryland
University of Maryland School of Dentistry
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Sunstar Americas
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Responsible Party: Sunstar Americas
ClinicalTrials.gov Identifier: NCT02221557    
Other Study ID Numbers: 2014-7-1-1
First Posted: August 20, 2014    Key Record Dates
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017
Last Verified: July 2017